On Dose to Throw Diverters Off Course

A former FBI director and drug company security executive says that protection must go beyond the package.

A side-by-side comparison of a regular pill and a NanoEncrypted pill. NanoGuardian's technology is so discreet, that to the naked eye there is no discernable difference between the pills.

Cracking opioid diversion or counterfeiting cases presents law enforcement with significant challenges. The diverters are certainly cunning and resourceful. But the bigger challenge may be in identifying that a crime has been committed. Save from criminal possession, what other evidence can prove diversion?

“Unfortunately, in the case of illegally diverted opioids, the information at hand is usually quite minimal, given that the medication is typically repackaged from its original container and the medication itself carries no information as to the intended site of distribution,” writes Dr. John Glover in the white paper titled, The Importance of On-Dose Technologies in the Fight Against Misuse, Abuse, and Illegal Diversion of Opioids. “This lack of on-dose source information presents a challenge for law enforcement seeking to initiate investigations.”

Glover, now president of John Glover Consulting Inc., has served as vice president of corporate security for Bristol-Myers Squibb as well as assistant director for administration at the FBI. In addition to consulting, he currently serves as chair of the security advisory board for NanoGuardian (Skokie, IL). NanoGuardian, a division of NanoInk, provides on-dose, multilayered technologies for brand protection and product authentication.

The FDA Amendments Act of 2007 authorized the agency to require risk evaluation and mitigation strategies (REMS) for certain drugs and biological products. REMS are required to manage a known or potential serious risk associated with a product, which can include risks associated with drug abuse, overdose, and withdrawal. “Opioid products already have established RiskMAP programs with education and outreach programs as the cornerstones to battle misuse and diversion, but these programs have failed to stem the growing tide of illicit diversion, misuse, and abuse,” he says.

Opioid manufacturers also have employed RFID to track packages through the supply chain, notes Glover. But he argues that RFID and other on-package technologies including serialization and 2-D bar codes don’t address the fact that opioids are often repackaged, leaving dispensed opioids with no remaining means of tracking. “On their own, package-securing technologies are ineffective in addressing the issue of illegal diversion, misuse, and abuse,” he writes.

In addition to package tracking, opioid and other pharmaceutical manufacturers should adopt on-dose technologies, Glover writes. “Dose-level tracing technology provides many benefits necessary for a successful opioid-specific REMS.” For instance, on-dose technology does not require equipment or participation of downstream supply-chain members to be effective. And since the technology resides on each and every dose, repackaging by criminals, as well as legitimate supply-chain members, has no effect on the tracing information that each dose can communicate to manufacturers, regulators, and law enforcement, thereby greatly enhancing investigational activities and providing keen insight into the flow of illegally diverted product through the supply chain.

The information associated with certain on-dose technologies is virtually unlimited and can include the capacity to associate the drug dose with on-package technologies such as RFID, creating a parent-child relationship between packaging and the dose.
Glover’s white paper discusses how NanoGuardian’s NanoEncryption technology can be a key element in opioid-specific REMS. “On-dose technologies, such as NanoGuardian’s NanoEncryption technology, can greatly assist manufacturers, law enforcement, and government agencies in mitigating illicit diversion and the resulting misuse and abuse, by providing distribution-tracing information on each and every dose of a medication.”

A copy of the white paper is available at www.nanoguardian.net/White Paper - On Dose Technology in the Fight Against Illegal Diversion of Opioid Meds.pdf. ■